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Clinical Trial Summary

Based on the basic data of all patients foreseen for a local hyperthermia in the participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the complication rate (injury to the patients) will be recorded.

Clinical Trial Description

During this PMCF Trial from each participating center the internal data of all Celsius TCS Hyperthermia devices are collected. The participating centers are obligated to report any device-related failure and Adverse Event (injury to the patient). The center reports together with the device-internal data allows to calculate the failure and the complication rates. It will be analyzed regarding the kind of tumor and the concomitant treatment (radiotherapy and/or chemotherapy). The outcome groups (with/without failure or complication) will be analyzed regarding demographic and treatment parameters. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

NCT number NCT02896049
Study type Observational [Patient Registry]
Source Celsius42 GmbH
Contact Eike G. Fischer, PhD
Phone +49 241 4500 358
Status Not yet recruiting
Phase N/A
Start date November 2016
Completion date October 2018

See also
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